Basic information on the surgical procedures for the ... this guide The Basic Information on the...

32
Basic information on the surgical procedures for the Straumann® Bone Level Tapered Implant

Transcript of Basic information on the surgical procedures for the ... this guide The Basic Information on the...

Page 1: Basic information on the surgical procedures for the ... this guide The Basic Information on the Surgical Procedures for the Straumann® Bone Level Tapered Implant provide dental practitioners

Basic information on the surgical procedures for the Straumann® Bone Level Tapered Implant

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About this guide

The Basic Information on the Surgical Procedures for the Straumann® Bone Level Tapered Implant provide dental practitioners and related specialists with the essential steps regarding surgical treatment and procedures for the Straumann® Bone Level Tapered Implant.

It is assumed that the user is familiar with placing dental implants. For further information, please see the Basic Information on the Surgical Procedures – Straumann® Dental Implant System, 152.754, and other existing Straumann procedure manuals that are referred throughout this document.

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Contents

1 The Straumann® Bone Level Tapered Implant 2

2 Implant features and benefits 32.1 Design features 3

2.2 Material 4

2.3 Surface 4

2.4 Transfer piece 4

2.5 Prosthetic connection 5

3 Indications 6

4 Planning 64.1 Preoperative planning 6

4.2 Planning aids 11

5 Surgical procedure 135.1 Workflow 13

5.2 Implant bed preparation 16

5.3 Implant placement 18

5.4 Soft tissue management 20

6 Instruments 216.1 Depth marks on Straumann instruments 21

6.2 Cleaning and care of instruments 22

6.3 Straumann® Surgical Cassette 23

7 Product reference list 247.1 Implants 24

7.2 Instruments 25

7.3 Auxiliary parts 26

8 Important guidelines 27

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1 The Straumann® Bone Level Tapered Implant

The Straumann® Dental Implant System offers two different implant lines, the Soft Tissue Level Implants and the Bone Level Implants.

The Bone Level Implants are suitable for bone level treatments in combination with transgingi-val or subgingival healing. The rough implant surface extends to the top of the implant and the connection is shifted inwards.

The Straumann® Bone Level Tapered Implant features the established and clinically proven Straumann® Bone Control Design™ and the CrossFit® connection together with its correspond-ing prosthetic CrossFit® components from the Bone Level Implant product portfolio. It has an apically tapered and self-cutting design, making this implant particularly suitable for situations involving soft bone/very soft bone or fresh extraction sockets where primary stability is key.

Straumann® Dental Implant System

Soft Tissue Level Implants Bone Level Implants

S SP TE BL BLT

Straumann®Standard PlusImplant (SP)

Straumann®Standard

Implant (S)

Straumann®Tapered Effect

Implant (TE)

Straumann®Bone Level

Implant (BL)

Straumann®Bone Level

TaperedImplant (BLT)

The Straumann® Bone Level Tapered Implant comes in the materials Roxolid® with the SLActive® and SLA® surface, or titanium with an SLA® surface.*A unified color code simplifies identification of instruments and implants for the three available endosteal diameters of ∅ 3.3 mm, ∅ 4.1 mm, and ∅ 4.8 mm.

Color coding

yellow Endosteal implant diameter 3.3 mm

red Endosteal implant diameter 4.1 mm

green Endosteal implant diameter 4.8 mm

* Some of the Straumann products listed here may not be available in all countries.

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2 Implant features and benefits

2.1 Design features

The Straumann® Bone Level Tapered Implant comes with a number of excellent features designed for convenient handling as well as outstanding clinical performance.

CrossFit® connection makes handling easier and

provides confidence for component positioning.

SLActive® surface allows fast and predictable

osseointegration.

Bone Control Design™ allows optimized crestal bone preserva-tion and soft tissue stability.

Roxolid® is a unique material with excellent mechanical properties.

Apically tapered implant body design allows underpreparation and supports a high primary stability in soft bone.

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2.2 Material

Roxolid® is a groundbreaking material specifically de-signed for the use in dental implantology. The titanium- zirconium alloy is stronger than pure titanium1,2 and has excellent osseointegration properties3-5. This combination of properties is unique in the market, there is no other metallic alloy which unifies high mechanical strength and osteoconductivity.

Thanks to their outstanding biological and mechan-ical properties, Roxolid® Implants offer more treat-ment options than conventional titanium implants.

2.3 Surface

SLActive® significantly accelerates the osseointegra-tion process and delivers everything you expect from a successful and patient-friendly implant treatment. ѹ Safer and faster treatment in 3-4 weeks for all

indications1⁶-25 ѹ Reduced healing times from 6 – 8 weeks down

to 3 – 4 weeks⁶-11 ѹ Increased treatment predictability in critical

protocols12

Most implant failures occur in the critical early peri-od between weeks 2 and 413. Although similar healing patterns were observed for both SLA® and SLActive® Implants, bone-to-implant contact (BIC) was greater after 2 weeks and significantly greater after 4 weeks for SLActive® (p-value < 0.05).14

2.4 Transfer piece

The Bone Level Tapered Implants are delivered with the Loxim™ Transfer Piece, which is connected to the implant with a snap-in mounting.

The SLActive® surface shows a faster integration into new bone after 4 weeks (50 %) compared to the SLA® surface (30 %).

Roxolid® shows a 20 % higher tensile strength than Straumann cold worked titanium and a 80 % higher strength than standard titanium Grade 4.

1000

~80%

~50%

~20%

800

600

400

ASTM TiGr4¹ Straumann® TiGr4

cold worked²Te

nsile

stre

ngth

[MPa

]

Straumann®Roxolid®²

0 %

10 %

20 %

30 %

40 %

50 %

60 %

70 %

Deg

ree

of n

ew b

one

on th

e im

plan

t sur

face

Healing periods in weeks1 2 3 4 5 6

Features Benefits

Snap-in mounting …… for easy handling without

counter-maneuvering

Blue color … … for high visibility

Compact dimensions … … for easy access

Height markings … … for correct implant placement

Pre-determined breaking point …

… avoids bone overcompression

SLActive® SLA®

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2.5 Prosthetic connection

The CrossFit® connection of Bone Level Implants applies the know-how and benefits from the Straumann® synOcta® Morse taper connection to the connection requirements at bone level. The mechanically locking friction fit of the 15° conical-cylindrical CrossFit® connection with four internal grooves has excellent long-term stability under all loading conditions and virtually eliminates screw loosening. Bone Level ∅ 4.1 mm and ∅ 4.8 mm Implants have the same connection, the Regular CrossFit® connection (RC), and they share the same secondary components. Bone Level ∅ 3.3 mm Implants feature the Narrow CrossFit® connection (NC).

For the CrossFit® connection, Straumann offers a broad range of standard and CADCAM abutments in leading materials and a full ap-plication range – designed to create the optimal restorative results for virtually any case. For ease of use, you need only one restorative kit for all Bone Level Implants. This single kit is easy to master, simple to handle and allows for convenient component management.

∅ 3.3 mm ∅ 4.1 mm ∅ 4.8 mm

* Base abutment providing flexible solutions ranging from cost effective to high esthetics

Single and multi-unit replacement Edentulous treatment

Screw-retained cement-retained Fixed Removable

Prem

ium

Gold Abutment

CARES® Abutment

ZrO2

Screw- retained

Abutment*

Gold Abutment

CARES® Abutment

ZrO2

CARES® Advanced Fixed Bar

Gold Abutment

Screw- retained

Abutment*

CARES® Milled Bar

Abutment for bars

gold

Screw- retained

Abutment*Adva

nced CARES®

Screw-retained Bridge

CARES® Abutment TAN

Anatomic Abutment, angled 15°

CARES® Abutment

Ti

CARES® Basic Fixed Bar

CARES® Screw-retained Bridge

CARES® Bar Abutment for bars

Ti

Stan

dard

Variobase™ Abutment Cementable

AbutmentLOCATOR®

Premium: Solution for cases requiring an enhanced degree of individualization combined with zirconia for high esthetics, or high noble gold alloysAdvanced: Technically advanced solution for cases requiring an enhanced degree of individualizationStandard: Cost-effective solution with standard components and techniques for straight forward cases

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To obtain more information about indications and contraindications related to each implant, please refer to the corresponding instructions for use. Instructions for use can be found on www.ifu.straumann.com

The Straumann® Bone Level Tapered Implants (BLT) are offered in three different diameters with distinctive features for each diameter:

3 Indications

4 Planning

Specific indications for Straumann implants:

Implant type Distinctive features Minimal ridge width*

Minimal gap width**

Available lengths

BLT ∅ 3.3 mm NCRoxolid®/TitaniumSLActive®/SLA®

▪ Small-diameter implant for narrow interdental spaces and bone ridges

5.5 mm 5.5 mm 8 – 16 mm

BLT ∅ 4.1 mm RCRoxolid®/TitaniumSLActive®/SLA®

▪ For oral endosteal implant indications in the maxilla and mandible, for functional and esthetic rehabilitation of edentulous and partially edentulous patients

6 mm 6 mm 8 – 16 mm

BLT ∅ 4.8 mm RCRoxolid®/TitaniumSLActive®/SLA®

▪ For oral endosteal implant indications in the maxilla and mandible, for functional and esthetic rehabilitation of edentulous and partially edentulous patients

▪ BLT ∅ 4.8 mm Implants are especially suited for wider interdental spaces and ridges

7 mm 7 mm 8 – 16 mm

* Minimal ridge width: Minimal orofacial ridge width, rounded off to 0.5 mm ** Minimal gap width: Minimal mesial-distal gap width for a single-tooth restoration, between adjacent teeth, rounded off to 0.5 mm

4.1 Preoperative planning

The implant is the focal point of the dental restoration. It provides the basis for planning the surgical procedure. Close communication between the patient, dentist, surgeon and dental technician is imperative for achieving the desired esthetic result.

To establish the topographical situation, the axial orientation, and the choice of implants, we recommend the following: ѹ Make a wax-up/set-up on the previously prepared study cast or use an implant planning software like

coDiagnostiX® in conjunction with the patient’s medical image data. ѹ Define the type of superstructure.

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The wax-up/set-up can later be used as the basis for a custom-made X-ray jig or drill template and for a temporary restoration.

The implant diameter, implant type, position and number of implants should be selected individually, taking the anatomy and spatial circumstances (e.g. malpositioned or inclined teeth) into account. The measurements given here should be regarded as minimum guidelines. Only when the minimum distances are observed it is possible to design the restoration so that the necessary oral hygiene measures can be carried out.

The final hard and soft tissue response is influenced by the position between the implant and the proposed restoration. Therefore, it should be based on the position of the implant-abutment connection. The implant position can be viewed in three dimensions: ѹ Mesiodistal ѹ Orofacial ѹ Coronoapical

Note: The abutments should always be loaded axially. Ideally, the long axis of the implant is aligned with the cusps of the opposing tooth. Extreme cusp formation should be avoided. It can lead to unphysiological loading.

Mesiodistal implant position The mesiodistal bone availability is an important factor for choosing the implant type and diameter as well as the inter-implant distances where multiple implants are placed. The point of reference on the implant for measuring mesiodistal distances is always the shoulder being the most voluminous part of the implant. Note that all distances given in this chapter are rounded off to 0.5 mm.

The following basic rules must be applied:

Rule 1: Distance to adjacent tooth at bone level A minimal distance of 1.5 mm from the implant shoulder to the adjacent tooth at bone level (mesial and distal) is required.

Rule 2: Distance to adjacent implants at bone level A minimal distance of 3 mm between two adjacent implant shoulders (mesiodistal) is required.

≥ 1.5 mm≥ 3 mm

Rule 1 Rule 2

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The following examples show how the rules 1 and 2 are implemented in multiple tooth gaps. The measurement is made at bone level from the adjacent tooth to the center of the implant and between implant centers. The minimal distance of 3 mm between two adjacent implant shoulders is important to facilitate flap adaptation, to avoid proximity of secondary components and to provide adequate space for maintenance and hygiene practices at home.

6.5 mm 3 mm 7 mm 7.5 mm 4 mm

∅ 3.3 mm ∅ 3.3 mm ∅ 4.1 mm ∅ 4.8 mm

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1 mm

Orofacial implant position The facial and palatal bone layer must be at least 1 mm thick in order to ensure stable hard and soft tissue conditions. The minimal orofacial ridge widths for in-dividual implant types are given in the indication in chapter 3 Indications. Within this limitation, a restoration-driven orofacial implant position and axis should be chosen such that screw-retained restorations are possible.

Caution: An augmentation procedure is indicated where the orofacial bone wall is less than 1 mm or a layer of bone is missing on one or more sides. This technique should be employed only by dentists who have adequate experience in the use of augmentation procedures.

The layer of bone must be at least 1 mm thick.

Choose the orofacial implant position and axis such that the screw channel of the screw- retained restoration is located behind the incisial edge.

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Coronoapical implant position Straumann implants allow for flexible coronoapical implant positioning, depending on individual anatomy, implant site, the type of restoration planned, and preference.

The Bone Level Tapered Implant is best placed with the outer rim of the small 45° sloping edge (chamfer) at bone level.

Ideally, in the esthetic region, the implant shoulder should be positioned about 3 – 4 mm subgingival of the prospective gingival margin. The round markings in the Loxim™ Transfer Piece indicate the distance to the implant shoulder in 1 mm steps.

0 mm (Bone Level)1 mm2 mm3 mm4 mm

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4.2.2 coDiagnostiX®There is also the possibility of a digital planning with coDiagnostiX®. This 3D diagnostics and implant planning software is designed for the image-guided surgical planning of dental implants, including Bone Level Tapered Implants, which are included in the digital library of the system. Working with the software is based on a patient’s medical image data such as a CT (Computed Tomography) and DVT (Digital Volume Tomography) that is processed by coDiagnostiX®.

Planning includes the calculation of several views (such as virtual OPG or a 3-dimensional reconstruction of the image dataset) and the analysis of the image data and the placement of implants, abutments and drilling sleeves.

coDiagnostiX® software is designed for use by professionals with appropriate knowledge in implantology and surgical dentistry. For further information, please refer to the coDiagnostiX® Manual.

4.2 Planning aids

The vertical bone availability determines the maxi-mum allowable length of the implant that can be placed. For easier determination of the vertical bone availability, we recommend the use of an X-ray Tem-plate (Art No. 025.0003) with X-ray Reference Spheres (Art. No. 049.076V4).

4.2.1 Straumann® X-ray TemplatesThe X-ray Templates are used for measurement and comparison. They also assist the user in selecting the suitable implant type, diameter and length. Similar to the distortions that occur in X-rays, the implant di-mensions are shown on the individual templates with the corresponding distortion factors (1:1 to 1.7:1).

Determining each magnification factor or scale is facilitated by showing the X-ray Reference Sphere on the template. At first compare the size of the X-ray Reference Sphere on the patient’s X-ray with the size of the Reference Sphere on the template. Superim-pose the two pictures to find the correct scale. Then, determine the spatial relations around the implant

position, and establish the implant length and inser-tion depth.

For more information regarding the preparation of the X-ray jig with the Reference Spheres see the Basic Information on the Surgical Procedures – Straumann® Dental Implant System, 152.754.

Warning: For Bone Level Tapered Implants use only the X-ray Template specific to the Bone Level Tapered Implant.

025

.000

3/A/

000

10/1

4 E0

1014

(049.076V4) = ∅ 5.0 mm

Straumann® Bone Level Tapered Implant Straumann® Bone Level Tapered Implant

(049.076V4) = ∅ 6.0 mm

(049.076V4) = ∅ 5.5 mm (049.076V4) = ∅ 6.5 mm

1.0 : 1 1.2 : 1

1.3 : 11.1 : 1

02

46

810

1214

16

∅ 4.8 mm ∅ 4.1 mm ∅ 3.3 mm ∅ 4.8 mm ∅ 4.1 mm ∅ 3.3 mm

∅ 4.8 mm ∅ 4.1 mm ∅ 3.3 mm∅ 4.8 mm ∅ 4.1 mm ∅ 3.3 mm

02

46

810

1214

16

02

46

810

1214

16

02

46

810

1214

16

Straumann® Bone Level Tapered Implant Straumann® Bone Level Tapered Implant

0.4 mm

025.0003.indd 2 03.10.14 08:10

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4.2.3 Straumann® Implant Distance IndicatorThe Implant Distance Indicator is available for Bone Level Implants (Art. No. 026.0901) and can be used for the Bone Level Tapered Implants as well.

The four discs of the Implant Distance Indicator represent the shoulder diameters of the Bone Level Implants. The Implant Distance Indicator can be used to check the available space before the start of treatment or intraoperatively to mark the desired implant site.

Implant Distance Indicator for Straumann® Bone Level Implants and Bone Level Tapered Implants

Art. No. 026.0901

Leg label Disk diameter Corresponding implants

Leg 1 BL ∅ 4.1 ∅ 4.1 mm Bone Level Implants, Bone Level Tapered Implants ∅ 4.1 mm

Leg 2 BL ∅ 4.1 ∅ 4.1 mm Bone Level Implants, Bone Level Tapered Implants ∅ 4.1 mm

Leg 3 BL ∅ 3.3 ∅ 3.3 mm Bone Level Implants, Bone Level Tapered Implants ∅ 3.3 mm

Leg 4 BL ∅ 4.8 ∅ 4.8 mm Bone Level Implants, Bone Level Tapered Implants ∅ 4.8 mm

4.2.4 Straumann® Pro Arch GuideFor intraoperative visual and three-dimensional orientation of the implant angulation (mesial/distal) and oral parallelization, use the Straumann® Pro Arch Guide.

The Pro Arch Guide is used in edentulous jaws for surgical implant placement. The Pro Arch Guide can be easily bent to adapt to the dental arch. It is secured by drilling into the symphysis with a ∅ 2.2 mm Pilot Drill and a pin in the jaw. The drilling depth for the bone cavity of the pin is 10 mm. The drilling depth can be checked optically using the depth markings on the drills. For adjustment and disassembly use the TS Hexagonal Screwdriver (046.420).

For further information about treatment of edentulous patients and angulated placement of Bone Level Tapered Implants, please refer to the Basic information on screw-retained hybrid res-torations – Straumann® Pro Arch, 490.015.

Straumann® Pro Arch Guide (026.0016)

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For preparing the implant bed the Straumann® Surgical Cassette is used for all implant lines. The specific instruments to be used for the Bone Level Tapered Implants are marked with two colored rings (see chapter 6.1 Depth marks on Straumann instruments).

Depending on the bone density15 (type 1 = very hard bone, type 4 = very soft bone) different drill protocols should be applied for the Bone Level Tapered Implant. This provides the flexibility to adjust the implant bed preparation to the individual bone quality and anatomical situation.

5.1 Workflow

5.1.1 Straumann® Bone Level Tapered 3.3 mm NC

5 Surgical procedure

Very hard boneType 1

Type 2

Type 3

Type 4

Hard bone

Soft bone

Very soft bone

Pilot∅ 2.2 mm

BLT Drill∅ 2.8 mm

Profile Drill∅ 3.3 mm

BLT Tap∅ 3.3 mm

rpm max 800 600 300 15

A B C

Subgingival healing Transgingival healing

Delayed function Delayed function Immediate function

recommended steps

dense cortex only

Note: In soft bone and very soft bone situations with a dense cortex, it is recommended to use the Profile Drill to prepare the cortical aspect of the osteotomy.

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Pilot∅ 2.2 mm

BLT Drill∅ 2.8 mm

BLT Drill∅ 3.5 mm

Profile Drill∅ 4.1 mm

BLT Tap∅ 4.1 mm

rpm max 800 600 500 300 15

Note: In soft bone and very soft bone situations with a dense cortex, it is recommended to use the Profile Drill to prepare the cortical aspect of the osteotomy.

Very hard boneType 1

Type 2

Type 3

Type 4

Hard bone

Soft bone

Very soft bone

recommended steps

dense cortex only

A B C

Subgingival healing Transgingival healing

Delayed function Delayed function Immediate function

5.1.2 Straumann® Bone Level Tapered 4.1 mm RC

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Very hard boneType 1

Type 2

Type 3

Type 4

Hard bone

Soft bone

Very soft bone

recommended steps

dense cortex only

Pilot∅ 2.2 mm

BLT Drill∅ 2.8 mm

BLT Drill∅ 3.5 mm

BLT Drill∅ 4.2 mm

Profile Drill∅ 4.8 mm

BLT Tap∅ 4.8 mm

rpm max 800 600 500 400 300 15

Note: In soft bone and very soft bone situations with a dense cortex, it is recommended to use the Profile Drill to prepare the cortical aspect of the osteotomy.

A B C

Subgingival healing Transgingival healing

Delayed function Delayed function Immediate function

5.1.3 Straumann® Bone Level Tapered 4.8 mm RC

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Step 1 – Prepare alveolar ridge and mark implant positionCarefully reduce and smooth a narrow tapering ridge with a large Round Bur. This will provide a flat bone surface and a sufficiently wide area of bone. Mark the implantation site determined during the implant position planning with the ∅ 1.4 mm Round Bur.

Note: This step might be not applicable or different depending on the clinical situation (e.g. fresh extraction socket).

Step 2 – Implant axis and depthWith the ∅ 2.2 mm BLT Pilot Drill, mark the implant axis by drilling to a depth of about 6 mm. Insert the ∅ 2.2 mm Alignment Pin to check for correct implant axis orientation. Use the ∅ 2.2 mm BLT Pilot Drill to prepare the implant bed to the final preparation depth. If necessary, correct any unsatisfactory im-plant axis orientation. Use the ∅ 2.2 mm Alignment Pin again to check the implant axis and preparation depth.

Caution: At this point take an X-ray, particularly with vertically reduced bone availability. The Alignment Pin is inserted into the drilled area, which allows a comparative visualization of the drill hole in relation to the anatomical structures.

Step 3 – Widen implant bed to ∅ 2.8 mmWiden the implant bed with the ∅ 2.8 mm BLT Drill. If necessary, correct the implant bed position. Use the ∅ 2.8 mm Depth Gauge to check the preparation depth.

5.2 Implant bed preparation

Implant bed preparation on the example of a Bone Level Tapered Implant ∅ 4.1 mm/10 mm RC in very hard bone (type 1).

After opening the gingiva, the implant bed preparation begins with the preparation of the alveolar ridge (Step 1) and the marking of the implantation site with a Round Bur (Step 1), followed by the implant bed preparation with the BLT Pilot Drill and the BLT Drills (Step 2 and 4), according to the endosteal implant diameter. The implant bed is widened in the cortical layer with the BLT Profile Drill (Step 5) and the threads are precut with the BLT Tap (Step 6).

600 rpm

800 rpm

800 rpm

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Step 4 – Widen implant bed to ∅ 3.5 mmWiden the implant bed with the ∅ 3.5 mm BLT Drill. If necessary, correct the implant bed position.

Use the ∅ 3.5 mm Depth Gauge to check the preparation depth.

Step 5 – Profile drilling Shape the coronal part of the implant bed with the ∅ 4.1 mm Profile Drill by using the orientation features as guidelines for vertical po-sitioning.

Step 6 – Tap drilling Precut the threads with the ∅ 4.1 Tap Drill over the full depth of the implant bed preparation.

Caution: Profile Drills and Taps marked with two color rings must only be used for the Bone Level Tapered Implant system.

300 rpm

15 rpm

500 rpm

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5.3 Implant placement

A Straumann implant can be placed with the Handpiece or manually with the Ratchet.

Do not exceed the recommended maximum speed of 15 rpm when you use the Handpiece.

Note: Straumann® Bone Level Tapered Implants must be rotationally oriented for both, Hand-piece and Ratchet insertion (see Step 4).

The following step-by-step instructions show how a Bone Level Tapered Implant is placed with the Ratchet.

Step 1 – Attach Ratchet Adapter Hold the enclosed part of the implant carrier. Attach the Ratchet Adapter to the Loxim™. You hear a click when the Adapter is attached correctly.

Step 2 – Remove implant from the carrier Pull down the implant carrier and, simultaneously, lift the implant out of the implant carrier (keep your arms steady).

Step 3 – Place implant Place the implant with the Ratchet Adapter into the implant bed. Use the Ratchet to move the implant into its final position turning it clockwise.

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Step 4 – Correct implant orientation While approaching the final implant position, make sure that the height markings on the blue transfer part are oriented exactly orofacially. This positions the four protrusions of the internal connection for ideal prosthetic abutment orientation. A turn to the next marking corresponds to a vertical displacement of 0.2 mm.

Step 5 – Remove instruments with Loxim™ The Loxim™ can easily be re-inserted to finish an un-completed implant placement until the implant is ful-ly inserted. If the implant needs to be removed during implantation surgery, the Loxim™ allows for counter-clockwise turns. After insertion, detach the Loxim™ with the Adapter.

If an Insertion torque of over 35 Ncm is achieved be-fore the implant has assumed its final position, check that the implant bed preparation is correct to avoid bone overcompression. The Loxim™ is provided with a pre-determined breaking point at 80 Ncm to prevent damage to the inner configuration of the implant, thus ensuring the integrity of the interface for mount-ing the prosthesis.

After breakage of the Loxim™, the remaining part of the Loxim™ in the implant must be removed and the implant, if not fitted correctly, has to be unscrewed with a 48h Explantation Device. After that the im-plant bed is to be re-prepared and a new implant has to be inserted. For further details, please consult the brochure Guidance for Implant Removal, 152.806.

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Subgingival healing For subgingival healing (healing under closed mucoperiosteal flap) the use of a Closure Screw is recommended. Submucosal healing is suggested in esthetic indications and for implantations with simul-taneous guided bone restoration (GBR) or membrane technique. A second surgical procedure is required for uncovering the implant and insertion of the desired secondary component.

Transgingival healing – Delayed functionStraumann implants come with a versatile portfolio of Healing Abut-ments enabling soft-tissue sculpting during transgingival healing. They are recommended for intermediate use. After the soft-tissue healing phase they are replaced with the appropriate temporary or final restoration.

Transgingival healing – Immediate functionStraumann implants are suitable, within the scope of indications, for immediate and early restoration in single-tooth gaps and of eden-tulous or partially edentulous jaws. Good primary stability and an appropriate occlusal load are essential. For immediate provisional restoration, the Bone Level prosthetic portfolio offers a wide range of temporary and final abutments.

For further information please see the Basic Information on the Pros-thetic Procedures – Straumann® Bone Level System, 152.810.

5.4 Soft tissue management

After implantation, close the implant – hand-tightened – with a Closure Screw or a Healing Abutment to protect the implant. The surgeon can choose between subgingival and trans-gingival healing and has all options available for soft tissue management made possible through a set of secondary healing components.

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6.1 Depth marks on Straumann instruments

Straumann instruments have depth marks in 2 mm intervals that correspond to the available implant lengths. The bold mark on the drills represents 10 mm and 12 mm, whereas the lower edge of the mark corresponds to 10 mm and the upper edge to 12 mm.

Warning: Due to the function and design of the drills, the drill tip is 0.4 mm longer than the insertion depth of the implant.

Caution: Do not use the former Alignment Pins and Depth Gauges with the Bone Level Tapered Implant since they will indicate a wrong depth.

6 Instruments

0.4 mm

10 mm

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6.2 Cleaning and care of instruments

Careful treatment of all instruments is of the utmost importance. Even slight damage, for instance to the drill tips (e.g., when the drills are “thrown” into a bowl of water), impairs cutting performance and thus the clinical result. With correct and careful care, the high quality of the material and excellent workmanship ensure that the rotating instruments can be used repeatedly (up to a maximum of ten times is recommended). The Surgery Tracking Sheet for Straumann® Cutting Instruments, 152.755 helps to give an overview of how often the individual instruments have already been used.

Straumann instruments with high cutting performance are a basic requirement for successful implantation. The following should therefore be remembered: ѹ Never allow instruments to land on their tips. ѹ Use each instrument only for its intended purpose. ѹ Never let surgical residues (blood, secretion, tissue residues) dry on an instrument; clean im-

mediately after surgery. ѹ Thoroughly clean off incrustations with soft brushes only. Disassemble instruments, clean

cavities especially well. ѹ Never disinfect, clean (also ultrasound) or sterilize instruments made of different materials

together. ѹ Use only cleaning agents and disinfectants intended for the material and follow the instruc-

tions for use of the manufacturer. ѹ Rinse disinfectants and cleaning agents very thoroughly with water. ѹ Never leave or store instruments moist or wet.

For more detailed information please see the brochure Care and Maintenance of Surgical and Prosthetic In-struments, 152.008.

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6.3 Straumann® Surgical Cassette

The Surgical Cassette is used for the secure storage and sterilization of the surgical instruments and auxiliary instruments of the Straumann® Dental Implant System. The Surgical Cassette is made of a highly shock-proof thermoplastic, which has been proven for years in the medical area and is suitable for frequent sterilization in the autoclave.

The unified color code represents the workflow you need to fol-low. For information on how to equip the Surgical Cassette, please see the brochure Instrument List for Straumann® Surgical Cassette, 152.746

Endosteal implant diameter 3.3 mm Endosteal implant diameter 4.1 mm Endosteal implant diameter 4.8 mm

For guidelines for the sterilization of the Surgical Cassette, please see the brochure Care and Maintenance of Surgical and Prosthetic Instruments, 152.008.

BLT Implant Diameter: ∅ 3.3 mm

BLT Implant Diameter: ∅ 4.1 mm

BLT Implant Diameter: ∅ 4.8 mm

BLT Tap

BLT Profile Drill

BLT Pilot Drill ∅ 2.2 mm

BLT Drill ∅ 2.8 mm

BLT Drill ∅ 3.5 mm

BLT Drill ∅ 4.2 mm

61 67 74

64

152

29 31 33

28 30 32

35 37 39

34 36 38

41 43 45

40 42 44

47 49 51

46 48 50

55 58 53 56 59 54 57 60

2

3

4 6 8 105 7 9 1120 22 24 26

12 14 16 1813 15 17 1921 23 25 27

70 73

62 68 76

65 71 75

63 69 78 80

66 72 77 79

Instrument List for Straumann® Surgical Cassette

No. Picture Article Art. No.

1 Round Bur 044.004

2 Round Bur 044.003

3 Round Bur 044.022

4 Pilot Drill 1, short 044.210

5 Pilot Drill 1, long 044.211

6 Pilot Drill 2, short 044.214

7 Pilot Drill 2, long 044.215

8 Twist Drill PRO, short 044.250

9 Twist Drill PRO, long 044.251

10 Twist Drill PRO, short 044.254

11 Twist Drill PRO, long 044.255

12  BLT Pilot Drill, short 026.0001

13   BLT Pilot Drill, long 026.0002

14   BLT Drill, short 026.2200

15   BLT Drill, long 026.2201

16   BLT Drill, short 026.4200

17   BLT Drill, long 026.4201

18   BLT Drill, short 026.6200

19   BLT Drill, long 026.6201

20, 21 Alignment Pin046.458 or 046.703

22, 23Depth Gauge or Depth Gauge with Distance Indicator

046.455 or 046.704 or 046.705

24, 25 Depth Gauge 046.450 or 046.706

26, 27 Depth Gauge 046.451 or 046.707

28 SP Profile Drill, RN, short 044.086

29 SP Profile Drill, RN, long 044.087

30 SP Profile Drill, RN, short 044.088

31 SP Profile Drill, RN, long 044.089

32 SP Profile Drill, WN, short 044.084

No. Picture Article Art. No.

33 SP Profile Drill, WN, long 044.085

34 TE Profile Drill, RN, short 044.701

35 TE Profile Drill, RN, long 044.708

36 TE Profile Drill, RN, short 044.705

37 TE Profile Drill, RN, long 044.712

38 TE Profile Drill, WN, short 044.703

39 TE Profile Drill, WN, long 044.710

40 BL/NNC Profile Drill, short 026.2303

41 BL/NNC Profile Drill, long 026.2306

42 BL Profile Drill, short 026.4303

43 BL Profile Drill, long 026.4306

44 BL Profile Drill, short 026.6303

45 BL Profile Drill, long 026.6306

46 BLT Profile Drill, short 026.0003

47 BLT Profile Drill, long 026.0004

48 BLT Profile Drill, short 026.0005

49 BLT Profile Drill, long 026.0006

50 BLT Profile Drill, short 026.0007

51 BLT Profile Drill, long 026.0008

52 S/SP Tap for Adapter 044.575

53 S/SP Tap for Adapter 044.577

54 S/SP Tap for Adapter 044.579

55 BL/TE/NNC Tap for Adapter 026.2310

56 BL/TE Tap for Adapter 026.4310

57 BL/TE Tap for Adapter 026.6310

58 BLT Tap 026.0009

59 BLT Tap 026.0010

60 BLT Tap 026.0011

61 Adapter for Handpiece, extra short 046.470

62 Adapter for Handpiece, short 046.471

63 Adapter for Handpiece, long 046.472

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7 Product reference list

Art. No. Article Dimensions Material

Roxolid® SLActive®

021.3308 Bone Level Tapered Implant ∅ 3.3 mm SLActive® 8 mm Roxolid®

021.3310 Bone Level Tapered Implant ∅ 3.3 mm SLActive® 10 mm Roxolid®

021.3312 Bone Level Tapered Implant ∅ 3.3 mm SLActive® 12 mm Roxolid®

021.3314 Bone Level Tapered Implant ∅ 3.3 mm SLActive® 14 mm Roxolid®

021.3316 Bone Level Tapered Implant ∅ 3.3 mm SLActive® 16 mm Roxolid®

021.5308 Bone Level Tapered Implant ∅ 4.1 mm SLActive® 8mm Roxolid®

021.5310 Bone Level Tapered Implant ∅ 4.1 mm SLActive® 10 mm Roxolid®

021.5312 Bone Level Tapered Implant ∅ 4.1 mm SLActive® 12 mm Roxolid®

021.5314 Bone Level Tapered Implant ∅ 4.1 mm SLActive® 14 mm Roxolid®

021.5316 Bone Level Tapered Implant ∅ 4.1 mm SLActive® 16 mm Roxolid®

021.7308 Bone Level Tapered Implant ∅ 4.8 mm SLActive® 8 mm Roxolid®

021.7310 Bone Level Tapered Implant ∅ 4.8 mm SLActive® 10 mm Roxolid®

021.7312 Bone Level Tapered Implant ∅ 4.8 mm SLActive® 12 mm Roxolid®

021.7314 Bone Level Tapered Implant ∅ 4.8 mm SLActive® 14 mm Roxolid®

021.7316 Bone Level Tapered Implant ∅ 4.8 mm SLActive® 16 mm Roxolid®

Roxolid® SLA®

021.3508 Bone Level Tapered Implant ∅ 3.3 mm SLA® 8 mm Roxolid®

021.3510 Bone Level Tapered Implant ∅ 3.3 mm SLA® 10 mm Roxolid®

021.3512 Bone Level Tapered Implant ∅ 3.3 mm SLA® 12 mm Roxolid®

021.3514 Bone Level Tapered Implant ∅ 3.3 mm SLA® 14 mm Roxolid®

021.3516 Bone Level Tapered Implant ∅ 3.3 mm SLA® 16 mm Roxolid®

021.5508 Bone Level Tapered Implant ∅ 4.1 mm SLA® 8 mm Roxolid®

021.5510 Bone Level Tapered Implant ∅ 4.1 mm SLA® 10 mm Roxolid®

021.5512 Bone Level Tapered Implant ∅ 4.1 mm SLA® 12 mm Roxolid®

021.5514 Bone Level Tapered Implant ∅ 4.1 mm SLA® 14 mm Roxolid®

021.5516 Bone Level Tapered Implant ∅ 4.1 mm SLA® 16 mm Roxolid®

021.7508 Bone Level Tapered Implant ∅ 4.8 mm SLA® 8 mm Roxolid®

021.7510 Bone Level Tapered Implant ∅ 4.8 mm SLA® 10 mm Roxolid®

021.7512 Bone Level Tapered Implant ∅ 4.8 mm SLA® 12 mm Roxolid®

021.7514 Bone Level Tapered Implant ∅ 4.8 mm SLA® 14 mm Roxolid®

021.7516 Bone Level Tapered Implant ∅ 4.8 mm SLA® 16 mm Roxolid®

Titanium SLA®

021.3408 Bone Level Tapered Implant ∅ 3.3 mm SLA® 8 mm Titanium

021.3410 Bone Level Tapered Implant ∅ 3.3 mm SLA® 10 mm Titanium

021.3412 Bone Level Tapered Implant ∅ 3.3 mm SLA® 12 mm Titanium

021.3414 Bone Level Tapered Implant ∅ 3.3 mm SLA® 14 mm Titanium

021.3416 Bone Level Tapered Implant ∅ 3.3 mm SLA® 16 mm Titanium

021.5408 Bone Level Tapered Implant ∅ 4.1 mm SLA® 8 mm Titanium

021.5410 Bone Level Tapered Implant ∅ 4.1 mm SLA® 10 mm Titanium

021.5412 Bone Level Tapered Implant ∅ 4.1 mm SLA® 12 mm Titanium

021.5414 Bone Level Tapered Implant ∅ 4.1 mm SLA® 14 mm Titanium

021.5416 Bone Level Tapered Implant ∅ 4.1 mm SLA® 16 mm Titanium

021.7408 Bone Level Tapered Implant ∅ 4.8 mm SLA® 8 mm Titanium

021.7410 Bone Level Tapered Implant ∅ 4.8 mm SLA® 10 mm Titanium

021.7412 Bone Level Tapered Implant ∅ 4.8 mm SLA® 12 mm Titanium

021.7414 Bone Level Tapered Implant ∅ 4.8 mm SLA® 14 mm Titanium

021.7416 Bone Level Tapered Implant ∅ 4.8 mm SLA® 16 mm Titanium

7.1 Implants

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Art. No. Article Dimensions Material

Bone Level Tapered Drills

026.0001 BLT Pilot Drill short Length 33 mm, ∅ 2.2 mm Stainless steel

026.0002 BLT Pilot Drill long Length 41 mm, ∅ 2.2 mm Stainless steel

026.2200 BLT Drill short Length 33 mm, ∅ 2.8 mm Stainless steel

026.2201 BLT Drill long Length 41 mm, ∅ 2.8 mm Stainless steel

026.4200 BLT Drill short Length 33 mm, ∅ 3.5 mm Stainless steel

026.4201 BLT Drill long Length 41 mm, ∅ 3.5 mm Stainless steel

026.6200 BLT Drill short Length 33 mm, ∅ 4.2 mm Stainless steel

026.6201 BLT Drill long Length 41 mm, ∅ 4.2 mm Stainless steel

Bone Level Tapered Profile Drills

026.0003 BLT Profile Drill short Length 25 mm, ∅ 3.3 mm Stainless steel

026.0004 BLT Profile Drill long Length 33 mm, ∅ 3.3 mm Stainless steel

026.0005 BLT Profile Drill short Length 25 mm, ∅ 4.1 mm Stainless steel

026.0006 BLT Profile Drill long Length 33 mm, ∅ 4.1 mm Stainless steel

026.0007 BLT Profile Drill short Length 25 mm, ∅ 4.8 mm Stainless steel

026.0008 BLT Profile Drill long Length 33 mm, ∅ 4.8 mm Stainless steel

Bone Level Tapered Taps

026.0009 BLT Tap Length 25 mm, ∅ 3.3 mm Stainless steel/TAN

026.0010 BLT Tap Length 25 mm, ∅ 4.1 mm Stainless steel/TAN

026.0011 BLT Tap Length 25 mm, ∅ 4.8 mm Stainless steel/TAN

Alignment Pin and Depth Gauges

046.703 Alignment Pin Length 27 mm, ∅ 2.2 mm Titanium

046.704Depth Gauge, with Distance Indicator

Length 27 mm, ∅ 2.2/2.8 mm Titanium

046.705 Depth Gauge Length 27 mm, ∅ 2.8 mm Titanium

046.706 Depth Gauge Length 27 mm, ∅ 3.5 mm Titanium

046.707 Depth Gauge Length 27 mm, ∅ 4.2 mm Titanium

7.2 Instruments

Note: Some of the Straumann products listed here may not be available in all countries. Please contact your country sales repre-sentative for details.

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7.3 Auxiliary parts

Art. No. Article Dimensions Material

046.119 Ratchet includes service instrument

Length 84 mm Stainless steel

045.111V4 Cleaning Brush for Ratchet

Length 100 mm, ∅ 4.5 mm

Stainless steel/Nylon

046.049Torque Control Device for Ratchet

Length 82 mm Stainless steel

046.064 Holding Key Length 85 mm Stainless steel

026.2558 Release Aid N for Loxim™ Length 90 mm Stainless steel

026.4558 Release Aid R/W for Loxim™ Length 90 mm Stainless steel

046.460Adapter for Ratchet, extra short

Length 11 mm Stainless steel

046.461Adapter for Ratchet, short

Length 18 mm Stainless steel

046.462Adapter for Ratchet, long

Length 28 mm Stainless steel

046.470Adapter for Handpiece, extra short

Length 19 mm Stainless steel

046.471Adapter for Handpiece, short

Length 26 mm Stainless steel

046.472Adapter for Handpiece, long

Length 34 mm Stainless steel

046.400SCS Screwdriver for Ratchet, extra short

Length 15 mm Cronidur® 30

046.401SCS Screwdriver for Ratchet, short

Length 21 mm Cronidur® 30

046.402SCS Screwdriver for Ratchet, long

Length 27 mm Cronidur® 30

046.410SCS Screwdriver for Handpiece, extra short

Length 20 mm Cronidur® 30

046.411SCS Screwdriver for Handpiece, short

Length 26 mm Cronidur® 30

046.412SCS Screwdriver for Handpiece, long

Length 32 mm Cronidur® 30

026.204848h Explantation Device for Bone Level NC Implants

∅ 8 mm, Length 31.4 mm Stainless steel

026.404848h Explantation Device for Bone Level RC Implants

∅ 8 mm, Length 31.2 mm Stainless steel

046.421 Hexagonal Screwdriver Length 30 mm Stainless steel

026.0016 Straumann® Pro Arch Guide

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8 Important guidelines

Please notePractitioners must have appropriate knowledge and instruction in the handling of the Straumann CADCAM products or other Strau-mann products (“Straumann Products”) for using the Straumann Products safely and properly in accordance with the instructions for use.

The Straumann Product must be used in accordance with the in-structions for use provided by the manufacturer. It is the practi-tioner’s responsibility to use the device in accordance with these instructions for use and to determine, if the device fits to the indi-vidual patient situation.

The Straumann Products are part of an overall concept and must be used only in conjunction with the corresponding original com-ponents and instruments distributed by Institut Straumann AG, its ultimate parent company and all affiliates or subsidiaries of such parent company (“Straumann”), except if stated otherwise in this document or in the instructions for use for the respective Strau-mann Product. If use of products made by third parties is not rec-ommended by Straumann in this document or in the respective instructions for use, any such use will void any warranty or other obligation, express or implied, of Straumann.

AvailabilitySome of the Straumann Products listed in this document may not be available in all countries.

Caution In addition to the caution notes in this document, our products must be secured against aspiration when used intraorally.

ValidityUpon publication of this document, all previous versions are super-seded.

Documentation For detailed instructions on the Straumann Products contact your Straumann representative.

Copyright and trademarksStraumann® documents may not be reprinted or published, in whole or in part, without the written authorization of Straumann. Straumann® and/or other trademarks and logos from Straumann® mentioned herein are the trademarks or registered trademarks of Straumann Holding AG and/or its affiliates.

Explanation of the symbols on labels and instruction leaflets

Batch code

Catalogue number

Sterilized using irradiation

…min.

Lower limit of temperature

…max.

Upper limit of temperature

…max.

…min.

Temperature limitation

Caution: Federal law restricts this device to sale by or on the order of a dental profes-sional.

Number of use less one

Non-sterile

Caution, consult accompanying documents

Use by

Keep away from sunlight

0123

Straumann Products with the CE mark fulfill the requirements of the Medical Devices Directive 93/42 EEC

Consult instructions for use

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1 Norm ASTM F67 (states min. tensile strength of annealed titanium). 2 Data on file for Straumann cold-worked titanium and Roxolid® Implants, MAT 13336, 20131009. 3 Gottlow J et al. : Evaluation of a new titanium-zirconium dental implant: a biomechanical and histological comparative study in the mini pig. Journal of Clinical Implant Dentistry and Related Research 2012; 14: 538-545 4 Wen B et al. : The osseointegration behavior of titanium-zirconium implants in ovariectomized rabbits. Clin Oral Implants Res. 2013 Feb 21. 5 Barter S et al. : A pilot study to evaluate the success and survival rate of titanium-zirconium implants in partially edentulous patients: results after 24 months of follow-up. Clin Oral Implants Res. 2012 Jul;23(7):873-81 6 Buser D et al. : Enhanced bone apposition to a chemically modified SLA titanium surface. J. Dent. Res. 2004 Jul;83(7):529–33. 7 Schwarz F et al. : Histological and immunohistochemical analysis of initial and early osseous integration at chemically modified and conventional SLA® titanium implants: Preliminary results of a pilot study in dogs. Clin. Oral Impl. Res. 2007;11(4):481–488. 8 Schwarz F et al. : Histological and immunohistochemical analysis of initial and early subepithelial connective tis-sue attachment at chemically modified and conventional SLA® titanium implants. A pilot study in dogs. Clin. Oral Impl. Res. 2007;11(3):245–455. 9 Schwarz F et al. : Effects of surface hydrophilicity and microtopography on early stages of soft and hard tissue integration at non-submerged titanium implants: An immunohistochemical study in dogs. J. Periodontol. 2007;78(11):2171–2184. 10 Schwarz F et al. : Bone regeneration in dehiscence-type defects at chemical-ly modified (SLActive) and conventional SLA titanium: A pilot study in dogs. J. Clin. Periodontol. 2007;34(1):78–86. 11 Zöllner et al. : Immediate and early non-occlusal loading of Straumann implants with a chemically modified surface (SLActive®) in the posterior mandible and maxilla: interim results from a prospective multicentre randomized-controlled study. Clinical Oral Implants Research, 19(5), 442-450,2008. 12 Nicolau P et al. : Immediate and early loading of chronically modified implants in posterior jaws: 3-year results from a prospective randomized study. Clin Implant Dent Relat Res. 2013 Aug;15(4):600-612 13 Raghavendra S et al. Int. J. Oral Maxillofac. Implants. 2005 May–Jun;20(3):425–31. 14 Lang, NP et al. : Early osseointegration to hydrophilic and hydrophobic implant surfaces in humans. Clin Oral Implants.Res 22.4 (2011): 349–56 15 Lekholm U et al. : Patient selection and preparation. Tissue integration prostheses. Chicago: Quintessence Publishing Co. Inc. 1985; 199-209 16 Rupp F et al. : Enhancing surface free energy and hydrophilicity through chemical modification of micro structured titanium implant surfaces. Journal of Biomedical Materials Research A, 76(2):323-334, 2006. 17 DeWild M : Superhydrophilic SLActive® implants.Straumann document 151.52, 2005 18 Maniura K : Laboratory for Materials – Biology Interactions Empa, St. Gallen, Switzerland Protein and blood adsorption on Ti and TiZr implants as a model for osseointegration. EAO 22nd Annual Scientific Meeting, October 17 – 19 2013, Dublin 19 Schwarz F et al. : Bone regeneration in dehiscence-type defects at non-submerged and submerged chemically modified (SLActive®) and conventional SLA® titanium implants: an immunohistochemical study in dogs. J Clin.Periodontol. 35.1 (2008): 64– 75. 20 Rausch-fan X et al. : Differentiation and cytokine synthesis of human alveolar osteoblasts compared to osteoblast-like cells (MG63) in response to titanium surfaces. Dental Materials 2008 Jan;24(1):102-10. Epub 2007 Apr 27. 21  Schwarz F et al. : Histological and immunohistochemical analysis of initial and early osseous integration at chemically modified and conventional SLA® titanium implants: Preliminary results of a pilot study in dogs. Clinical Oral Implants Research, 11(4): 481-488, 2007. 22 Lang, NP et al. : Early osseointe-gration to hydrophilic and hydrophobic implant surfaces in humans. Clin Oral Implants.Res 22.4 (2011): 349–56. 23 Raghavendra S et al. : Int. J. Oral Maxillofac. Implants. 2005 May–Jun;20(3):425–31. 24 Oates TW et al. : Enhanced implant stability with a chemically modified SLA® surface: a randomized pilot study. Int. J. Oral Maxillofac. Implants. 2007;22(5):755–760. 25 Schwarz F et al. : Bone regeneration in dehiscence-type defects at chemically modified (SLActive®) and conventional SLA® titanium implants: a pilot study in dogs. J Clin.Periodontol. 34.1 (2007): 78–86

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International Headquarters Institut Straumann AG Peter Merian-Weg 12 CH-4002 Basel, Switzerland Phone +41 (0)61 965 11 11 Fax +41 (0)61 965 11 01 www.straumann.com

© Institut Straumann AG, 2015. All rights reserved.Straumann® and/or other trademarks and logos from Straumann® mentioned herein are the trademarks or registered trademarks of Straumann Holding AG and/or its affiliates.

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0.03

8/en

/C/0

0 10

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